Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00362882
First received: August 10, 2006
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

This trial is studying two different schedules of docetaxel and bortezomib to compare how well they work in treating patients with progressive or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with bortezomib may kill more tumor cells


Condition Intervention Phase
Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Drug: docetaxel
Drug: bortezomib
Other: laboratory biomarker analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: pharmacological study
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Sequential Versus Concurrent Docetaxel and PS-341 (NSC 681239, IND 58,443) in Previously Treated Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate for PS-341 and docetaxel given in two sequences and to decide whether this combination warrants further study [ Time Frame: Up to 4 years ] [ Designated as safety issue: Yes ]
    This objective corresponds to a one-sided test at the 0.5 level of significance, with 90% power.


Secondary Outcome Measures:
  • Duration of overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Will be estimated using the product-limit method of Kaplan and Meier.

  • Time to progression [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
    Will be estimated using the product-limit method of Kaplan and Meier.

  • Progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2006
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8.
Drug: docetaxel
Given IV
Other Names:
  • RP 56976
  • Taxotere
  • TXT
Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Other: laboratory biomarker analysis
correlative study
Other: immunoenzyme technique
correlative study
Other Name: immunoenzyme techniques
Other: immunohistochemistry staining method
correlative study
Other Name: immunohistochemistry
Other: pharmacological study
correlative study
Other Name: pharmacological studies
Experimental: Arm 2
Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.
Drug: docetaxel
Given IV
Other Names:
  • RP 56976
  • Taxotere
  • TXT
Drug: bortezomib
Given IV
Other Names:
  • LDP 341
  • MLN341
  • VELCADE
Other: laboratory biomarker analysis
correlative study
Other: immunoenzyme technique
correlative study
Other Name: immunoenzyme techniques
Other: immunohistochemistry staining method
correlative study
Other Name: immunohistochemistry
Other: pharmacological study
correlative study
Other Name: pharmacological studies

Detailed Description:

PRIMARY OBJECTIVE:

I. To compare the efficacy and tolerability of sequential vs concurrent docetaxel and bortezomib in patients with previously treated, progressive or recurrent, advanced non-small cell lung cancer (NSCLC).

SECOND OBJECTIVES:

I. To compare time to progression in patients with previously treated NSCLC treated with these regimens.

II. To compare 1-year and overall survival of patients treated with these regimens.

III. To compare the toxicity of these regimens in these patients. IV. To determine the pharmacokinetics of docetaxel in the context of this study.

TERTIARY OBJECTIVE:

I. To determine levels of expression of molecular markers regulated by docetaxel and bortezomib and correlate with clinical response and overall survival of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and number of prior chemotherapy treatments (1 vs >1). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Criteria:

  • No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for 5 years.
  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
  • Progressive or recurrent NSCLC after treatment with 1 prior platinum-based chemotherapy regimen for metastatic disease. Prior neoadjuvant/adjuvant chemotherapy and/or concurrent chemoradiation for early-stage disease allowed.
  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered.
  • No prior docetaxel or bortezomib
  • Prior epidermal growth factor receptor inhibitor therapy allowed.
  • Prior paclitaxel allowed
  • At least 4 weeks since prior major surgery and recovered.
  • At least 2 weeks since prior and no concurrent enzyme-inducing anticonvulsants.
  • No concurrent hormonal therapy, biologic therapy, or radiotherapy to measurable lesions. Concurrent palliative radiotherapy to small-field nonindicator lesions (e.g., painful bony metastases) allowed.
  • Measurable disease* with >= 1 unidimensionally objectively measurable lesion, including any of the following:
  • Lung mass (measurable on chest x-ray, tomograms, or CT scan)
  • Enlarged lymph nodes
  • Liver metastasis (measurable as a discrete focal lesion on radionuclide or CT scan, or ultrasound)
  • Metastatic abdominal mass (measurable on CT scan with >= 1 perpendicular diameter ≥ the distance between cuts)
  • Measurable disease must be outside the previous radiation field or a new lesion must be present.
  • Life expectancy >= 12 weeks
  • Progressive disease within a previously radiated field allowed.
  • [Note: *Measurable disease DOES NOT include bone metastases or non-focal liver metastases].
  • No symptomatic or untreated brain metastasis requiring steroids. Asymptomatic, previously treated (surgical resection or radiotherapy) brain metastasis allowed provided they are neurologically stable and >= 4 weeks since prior steroids.
  • Creatinine clearance >= 50 mL/min
  • Creatinine =< 1.6 mg/dL
  • Bilirubin normal
  • AST =< 2 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No peripheral neuropathy >= grade 2
  • Absolute granulocyte count >= 1,500/mm³
  • Platelet count >= 100,000/mm³
  • Cutaneous nodule
  • ECOG performance status 0-1
  • At least 4 weeks since prior radiotherapy and recovered.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362882

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
Investigators
Principal Investigator: Primo Lara City of Hope Medical Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00362882     History of Changes
Other Study ID Numbers: NCI-2009-00123, PHII-70, N01CM17101, CDR0000491470
Study First Received: August 10, 2006
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014